Tazorac

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Do not freeze.

Tazarotene foam is flammable, keep it away from flames and extreme heat. Do not puncture or incinerate the tazarotene foam container.

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

This medication was withdrawn from the US market on March 30, 2007, but it available on a very limited basis for restricted use. Women who would like to be considered for this medication should contact their doctor for an evaluation.

Tazarotene is a topical acne and psoriasis medication. The exact mechanism of how tazarotene works is not known. Scientists believe that when tazarotene is applied to the skin, it affects the growth of skin cells and thereby reduces the formation of pimples and psoriasis plaques. It may affect growth of skin cells by affecting the action of genes that control production of skin cells. It also reduces inflammation. The FDA approved tazarotene in June 1997.

• Allergan, Inc.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Tazorac falls into category X. It has been shown that women taking Tazorac during pregnancy may have babies born with problems. There are no situations where the benefits of the medication for the mother outweigh the risks of harm to the baby. These medicines should never be used by pregnant women.

Apply this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your age

The recommended dose of Tazorac for the treatment of acne and/or plaque psoriasis is a thin film applied only to the affected skin areas once per day in the evening.

• Store at 20°C to 25°C (68°F to 77°F)
• For external use only
• Wash hands after use
• Keep this and all medicines out of the reach of children

Retinoids may cause fetal harm when administered to a pregnant woman.

In rats, tazarotene 0.05% gel, administered topically during gestation days 6 through 17 at 0.25 mg/kg/day (1.5 mg/m2/day) resulted in reduced fetal body weights and reduced skeletal ossification. Rabbits dosed topically with 0.25 mg/kg/day (2.75 mg/m2 total body surface area/day) tazarotene gel during gestation days 6 through 18 were noted with single incidences of known retinoid malformations, including spina bifida, hydrocephaly, and heart anomalies. Systemic daily-exposure (AUCde) to tazarotenic acid at topical doses of 0.25 mg/kg/day tazarotene in a gel formulation in rats and rabbits represented 0.62 and 6.7 times, respectively, the AUC0-24h observed in psoriatic patients treated with 2 mg/cm2 of tazarotene gel 0.1% (extrapolated for topical application over a 20% body surface area), and 0.78 and 8.4 times, respectively, the maximum AUC0-24h in acne patients treated with 2 mg/cm2 of tazarotene gel 0.1% over a 15% (targeted) body surface area.

As with other retinoids, when tazarotene was given orally to experimental animals, developmental delays were seen in rats, and teratogenic effects and post-implantation loss were observed in rats and rabbits at AUCde values that were 0.55 and 13.2 times, respectively, the AUC0-24h observed in psoriatic patients treated with 2 mg/cm2 of tazarotene gel 0.1% (extrapolated for topical application over a 20% body surface area), and 0.68 and 16.4 times, respectively, the maximum AUC0-24h in acne patients treated with 2 mg/cm2 of tazarotene gel 0.1% over a 15% (targeted) body surface area.

In a study of the effect of oral tazarotene on fertility and early embryonic development in rats, decreased number of implantation sites, decreased litter size, decreased numbers of live fetuses, and decreased fetal body weights, all classic developmental effects of retinoids, were observed when female rats were administered 2 mg/kg/day from 15 days before mating through gestation day 7. A low incidence of retinoid-related malformations at that dose was reported to be related to treatment. This dose produced an AUCde that was 1.7 times the AUC0-24h observed in psoriatic patients treated with 2 mg/cm2 tazarotene gel 0.1% (extrapolated for topical application over a 20% body surface area) and 2.1 times the maximum AUC0-24h in acne patients treated with 2 mg/cm2 of tazarotene gel 0.1% over a 15% (targeted) body surface area.

SYSTEMIC EXPOSURE TO TAZAROTENIC ACID IS DEPENDENT UPON THE EXTENT OF THE BODY SURFACE AREA TREATED. IN PATIENTS TREATED TOPICALLY OVER SUFFICIENT BODY SURFACE AREA, EXPOSURE COULD BE IN THE SAME ORDER OF MAGNITUDE AS IN THESE ORALLY TREATED ANIMALS. ALTHOUGH THERE MAY BE LESS SYSTEMIC EXPOSURE IN THE TREATMENT OF ACNE OF THE FACE ALONE DUE TO LESS SURFACE AREA FOR APPLICATION, TAZAROTENE IS A TERATOGENIC SUBSTANCE, AND IT IS NOT KNOWN WHAT LEVEL OF EXPOSURE IS REQUIRED FOR TERATOGENICITY IN HUMANS (SEE CLINICAL PHARMACOLOGY: PHARMACOKINETICS).

There were thirteen reported pregnancies in patients who participated in clinical trials for topical tazarotene. Nine of the patients were found to have been treated with topical tazarotene, and the other four had been treated with vehicle. One of the patients who was treated with tazarotene cream elected to terminate the pregnancy for non-medical reasons unrelated to treatment. The other eight pregnant women who were inadvertently exposed to topical tazarotene during clinical trials subsequently delivered apparently healthy babies. As the exact timing and extent of exposure in relation to the gestation times are not certain, the significance of these findings is unknown.

Tazorac® Gel is contraindicated in women who are or may become pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, treatment should be discontinued and the patient apprised of the potential hazard to the fetus. Women of child-bearing potential should be warned of the potential risk and use adequate birth-control measures when Tazorac® Gel is used. The possibility that a woman of child-bearing potential is pregnant at the time of institution of therapy should be considered. A negative result for pregnancy test having a sensitivity down to at least 50 mIU/mL for human chorionic gonadotropin (hCG) should be obtained within 2 weeks prior to Tazorac® Gel therapy, which should begin during a normal menstrual period (see also PRECAUTIONS: Pregnancy: Teratogenic Effects).

Tazorac® Gel is contraindicated in individuals who have shown hypersensitivity to any of its components.

General: Application may cause excessive irritation in the skin of certain sensitive individuals. In cases where it has been necessary to temporarily discontinue therapy, or the dosing has been reduced to a lower concentration (in patients with psoriasis) or to an interval the patient can tolerate, therapy can be resumed, or the drug concentration or frequency of application can be increased as the patient becomes able to tolerate the treatment. Frequency of application should be closely monitored by careful observation of the clinical therapeutic response and skin tolerance [see Precautions].

Tazorac Gel, 0.05% and 0.1%, are for topical use only. Tazorac Gel, 0.05% and 0.1%, are not for ophthalmic, oral, or intravaginal use.

Avoid accidental transfer of Tazorac Gel, 0.05% and 0.1%, into eyes, mouth, or other mucous membranes. If contact with mucous membranes occurs, rinse thoroughly with water [see Precautions].

Efficacy has not been established for less than once daily dosing frequencies.

For Psoriasis: It is recommended that treatment start with Tazorac® 0.05% Gel, with strength increased to 0.1% if tolerated and medically indicated. Apply Tazorac® Gel once a day, in the evening, to psoriatic lesions, using enough (2 mg/cm2) to cover only the lesion with a thin film to no more than 20% of body surface area. If a bath or shower is taken prior to application, the skin should be dry before applying the gel. If emollients are used, they should be applied at least an hour before application of Tazorac® Gel. Because unaffected skin may be more susceptible to irritation, application of tazarotene to these areas should be carefully avoided. Tazorac® Gel was investigated for up to 12 months during clinical trials for psoriasis.

For Acne: Cleanse the face gently. After the skin is dry, apply a thin film of Tazorac® Gel 0.1% (2 mg/cm2) once a day, in the evening, to the skin where acne lesions appear. Use enough to cover the entire affected area. Tazorac® Gel was investigated for up to 12 weeks during clinical trials for acne.

Tazorac® (tazarotene) Gel is available in concentrations of 0.05% and 0.1%. It is available in a collapsible aluminum tube with a tamper-evident aluminum membrane over the opening and a white propylene screw cap, in 30 g and 100 g sizes.

Storage: Store at 25°C (77°F): excursions permitted to 15-30°C (59-86°F).

Revised: 07/2017

© 2017 Allergan. All rights reserved.
All trademarks are the property of their respective owners.
Irvine, CA 92612
Made in the U.S.A.

71722US15

71722US15

NDC 0023-0042-10

Rx only

Tazorac®
(tazarotene) gel 0.1%

100 grams

For Dermatologic Use Only
Not for Ophthalmic Use

ALLERGAN®

NDC 0023-8335-10

Rx only

Tazorac®
(tazarotene) gel 0.05%

100 grams

For Dermatologic Use Only
Not for Ophthalmic Use

ALLERGAN®

Tazorac is used to treat psoriasis (scaly, itchy, and dry patches of skin) and acne.

Tazorac comes in the form of a cream or gel you apply to your skin.

Tazorac is the brand name for the drug tazarotene. It isn’t available as a generic drug.

The more common side effects of this drug include dry skin, itching, redness, and burning of your skin.

Tazorac can harm an unborn baby. If you can become pregnant, use a reliable form of birth control while taking Tazorac. If you do get pregnant, stop using Tazorac and call your doctor right away.

• Harm to an unborn baby See Details

• Skin irritation See Details

• Sensitivity to sunlight See Details

• Foam can catch on fire See Details

What is Tazorac?

This drug is a prescription drug. It’s available as a topical cream and topical gel.

Tazorac is the brand name for the drug tazarotene. This drug isn’t available as a generic drug.

This drug may be used as part of a combination therapy. This means you may need to take it with other medications.

Why it's used

This drug is used to treat psoriasis (scaly, itchy, and dry patches of skin), acne, and skin wrinkling and age spots on the face.

How it works

This drug belongs to a class of drugs called retinoids. A class of drugs is a group of medications that work in a similar way. These drugs are often used to treat similar conditions.

More Details